Orthopedic rigid splint-plate orthosis

ABSTRACT

An orthopedic rigid splint-plate orthosis comprises a splint-plate which is provided in one of a combination of different shapes and sizes corresponding to different body members which may have to be treated. The splint-plate has at one of its edges a non-stretchable linking ribbon which at the end thereof opposite to the end joined to the plate includes locking means which are complementary with corresponding locking means provided in the edge of the plate opposite to that edge joined with the ribbon. The plate is provided presterilized and isolated inside an impervious bag which may be filled with boiling water to make the rigid splint-plate soft, whereafter the water is drained and the softened plate applied and moulded to the body member and then left to harden back to its rigid state. For use in an operating theatre, the bag with the plate may be closed inside a second bag and sterilized with gas or radiation; thereafter, the plate may be softened by submerging the sealed outside bag in hot water.

BACKGROUND OF THE INVENTION

1. Field of the invention

The present invention relates to an orthopedic rigid bandage-plateorthosis or splint useful for medical applications, especially thoseapplications in which some parts of the human body have to be securedagainst movement during a predetermined therapeutic treatment period.This includes treatment for foot deviations such as various foot,metatarsus aductus, overlapping toes, pes talus and bunions; sprainedand fractured fingers and toes; sprained ankles; trigger finger;post-operative immobilization for neck, foot and hand surgery; genuvalgum; torticollis; scoliosis; thoracic trauma; and provisionalimmobilization. Other uses may be those related to aesthetic and plasticsurgery, and those in the veterinary field.

2. Description of prior art

Splints made of plastic-like materials are well-known in the art. Onekind of splint is provided in rigid form and has to be moistened inwater in order to be softened and wound around the human body member tobe protected.

Another kind of rigid orthosis comprises a thermoplastic material plateprovided in the form of a large sheet, from which each splint has to becut in the proper shape according to the injured human body member. Oncecut, the plastic rigid splint must be perforated and binding ribbonsriveted thereto. It is then sufficiently heated in a skillet, pan orother adequate means to transform the thermoplastic .[.materialito.]..Iadd.material into .Iaddend.a soft state, whereafter the orthosis maybe duly applied to and wrapped around the pertinent body member.Thereafter, the ribbons are wound around the splint and tied using aspecial adhesive to keep the splint in place until it cools and revertsto its normal rigid state.

In emergency situations, the time and expertise necessary to cut therigid bandage-plate in the proper shape and the need to prepare itrepresent important drawbacks. If trained personnel for cutting thisplate happen to be unavailable, when the emergency situation arises, itis very probable that incorrectly cut splints may be obtained.

Another drawback of the prior art method and means is due to theinvestment and cost of obtaining and keeping the large sheet materialfrom which the relatively small plates are cut from time to time.Furthermore, there are left-overs from the cut material which constitutesignificant wastes thereof.

Other drawbacks and disadvantages result from the initial lack ofsterilization of the thermoplastic sheet and the need of significantaccessories such as the skillet or pan, stove or heater, drill, riveter,special adhesive, etc. The initial lack of sterilization may bedangerous if the cut plate is not heated sufficiently, e.g. when thewater is warmed but not boiled, and furthermore, is inadmissable inoperating theatres. In fact, when sterilization is needed, an additionalstep is required using gas or radiation for sterilizing the splint.

These drawbacks generally limit the availability and use of thesesplints to hospitals and clinics and preclude widespread storage and usein private consulting-rooms.

BRIEF SUMMARY OF THE INVENTION

Therefore, an object of the present invention is to provide orthosismeans which may be bought individually, costing a fraction of theinvestment required by prior art means.

Another object of the present invention is to provide orthosis meanswhich may be applied without the need of accessory means, i.e. skillet,heater, tools or separate ribbons and adhesive.

Another object of the present invention is to provide orthosis meanswhich eliminate the waste of leftovers.

Another object of the present invention is to provide orthosis meanswhich drastically reduce the time and expertise necessary for preparingthe splint, such that it may be swiftly applied by the doctor himself.

Another object of the present invention is to provide orthosis meanswhich may be widely available and used in any type of medicalestablishment, large or small, including private consulating rooms.

Another object of the present invention is to provide orthosis meanswhich are assuredly sterilized.

Another object of the present invention is to provide orthosis meanswhich may be easily and safely used in operating theatres.

In order to overcome the above cited drawbacks and to realize saidobjects, the present invention provides orthopedic rigid splint-plateorthoses which are particularly adapted to different human body partswhich may have to be therapeutically treated, such that eachsplint-plate may form a rigid protection which can be directly mouldedon the skin of the patient without any risk of burning thereof. Thesplint-plate is made of thermoplastic material, the composition andthermoplastic characteristics of which are well-known in the art. Seefor example U.S. Pat. No. 4,600,618 issued Jul. 15, 1986. The rigidsplint-plate is provided within a bag made of a plastic material havinggood resistance to hot water. The splint is provided in the bag, saidsplint having already been cut in a specific shape and size, with atleast one fixing strip or ribbon attached at one edge of the splint. Thefree end of the strip has locking means which match complementarylocking means on the opposite edge of the splint or on the free end of asecond strip attached thereto.

The splints of the present invention are provided in the bags, saidsplints having already been sterilized the bags, and are made availablein different shapes and sizes, such that an individual practitioner needonly stock a small quantity of easily storable splint packets.

When needed, a bagged splint of the proper size is taken from thecupboard or appropriate storage means, and subjected to a heatingoperation while still inside the bag, so that the state of thesplint-plate is changed from rigid to soft. Thereafter, the thence softsplint-plate is removed from the bag and moulded by hand on the bodypart to be treated. Then the ribbon is wrapped around the soft splint tokeep it in place until it has hardened.

Consequently, in emergency situations, the rigid splint of the presentinvention is immediately available and easily usable and, therefore, thepatients run no risks due to time-delays and lack of personnel. Therigid splints, in accordance with the present invention, will have thecorrect shape for the corresponding human body part, since they will bemanufactured and precut by dedicated personnel skilled in this art. Theadvantages of this are that the proper splint will be simply selectedand correctly located for the pertinent human body part, even bynon-skilled personnel, due to its predetermined correct shape, and thusleftovers are eliminated. Sterilization of the splint is optional, and.Iadd.it .Iaddend.should only taken out of the bag once it has beenheated to its soft state. The .[.split.]. .Iadd.splint .Iaddend.is thusisolated from contamination during storage time, which may be quite longin small establishments. Furthermore, all contact with preparation toolsis eliminated, as is the need for special accessories to prepare thesplint. Sterilization is optional; in fact, an individual physician maysimply use hot water from his coffee maker to heat the splint prior toapplication, since boiling water is indeed not necessary if the splintis just to be softened.

According to a preferred embodiment, the present invention providesorthopedic splint-plate, orthoses, each comprising a thermoplasticmaterial splint-plate having a shape corresponding to the body member tobe treated, the plate having at one of its edge a linking strip orribbon made from a non-stretchable material joined thereto at one of itsends. At its opposite end, the linking strip includes locking meanscomplementary with locking means provided on the plate, at an edgeopposite to said one edge of the plate joined to the strip. The rigidplate is provided isolated in an impervious material bag which isaseptically closed, which bag is mechanically resistant to the weight ofthe splint-plate as well as thermally resistant to the temperature ofhot water up to and including boiling point. Prior to application, thebag is cut open at one end and hot fluid poured in to soften thesplintplate. Once the thermoplastic plate is soft, the heating fluid isemptied and the plate is removed from the bag. Thenceforth, the plate isready to be applied to a body.

Alternatively, to ultimately preserve sterilization of the splint, theclosed bag may be submerged in hot fluid to soften the plate inside andopened only for removal of the then-softened plate. For post-surgery usein an operating theatre, the original sealed bag with the plate insidemay be placed inside an additional bag which is sealably closed andsubjected to radiation or gas for sterilizing it and its contents.

In addition, the rigid splint-plate orthosis of the present inventionmay be provided with a foam padded surface which is intended to be incontact with the skin of the patient. The foam pad may be ofthermoplastic material. The plate may be gridded with holes tofacilitate skin breathing as well as saving material and providing alighter splint.

The present invention further features a method for immobilizing aninjured body member part during a treatment period, which methodcomprises the steps of providing a rigid splint-plate comprised ofthermoplastic material and thermally resistant bag means containing saidsplint-plate, the thermoplastic splint-plate having complementaryfastening means located at opposite sides thereof, subjecting said plateto a hot fluid to heat and relatively soften it whilst still inside thebag means, removing the softened splint-plate from said bag means andsaid hot fluid, applying said soft splint-plate to at least a part ofsaid injured body member and manually moulding it to substantiallyconform to the shape of said body member part, locking the softsplint-plate plate in place with said fastening means and waiting forsaid thermoplastic splint-plate to revert to its rigid state, wherebysaid rigid splint-plate firmly grips and immobilizes said injured bodymember part.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective general view of the rigid splint-plate orthosisof the invention, wherein the splint-plate is located within a bag readyfor sale.

FIG. 2 shows the bag of FIG. 1 with the rigid splint-plate removedtherefrom.

FIG. 3 illustrates the definite shape of the splint of FIGS. 1 and 2,once moulded, wrapped around and fastened to an (unillustrated) bodymember.

FIG. 3A shows the splint of FIG. 3 applied, for example, to correct abunion.

FIGS. 4 shows another way, from among many other possibilities, of usingthe orthosis of the present invention.

.Iadd.FIG. 5 shows the invention having a second bag. .Iaddend.

In the several Figures, the same reference numerals indicate the sameparts of the rigid splint-plate orthosis.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Consider first FIGS. 1 and 2. Reference numeral 1 generally indicatesthe orthopedic rigid splint-plate orthosis of the invention consistingof a thermoplastic splint-plate 2, which in accordance with a particularuse has one of several shapes and sizes, and a bag 9 which is made froman impervious material.

Splint-plate 2 includes a ribbon or strip 3, which is made from anon-stretchable and thermally resistant material. The strip 3 is joined,at one of its ends 4, to the splint-plate 2, by means of any suitablejoining means 8, such as a pair of stainless rivets. The other end 5 ofthe strip 3 includes locking means 6 which are complementary withcorresponding locking means 7 located in the splintplate 2. The lockingmeans 6 and 7 may be of any suitable nature, such as typical hook andloop means. In any case, the locking means 6, 7 and the joining means 8must be capable of firmly retaining the splint-plate around the bodymember of the patient, at least until the plate 2 is rigid.

As stated above, the splint-plate 2 is originally provided and storedwithin the bag 9 to keep it sterilized. This bag 9 may be made from aplastic material, laminar or not, but, in any case, the bag must becapable of resisting the weight of the splint-plate 2 as well as thetemperature of hot water, which is poured inside the bag 9 or in whichthe bag is submerged, in order to cause the plate 2 to adopt a softstate. Preferbly, the bag 9 has a pentagonal-like shape, in order todefine a tip 10 which may be cut to allow discharge of the water afterheating. Obviously, the bag 9 may have any other kind of configurationwhich allows discharge of the water upon requirement. In any case, thesplint-plate .[.orthesis.]. .Iadd.orthosis.Iaddend./and bag 9 willpreferably be aseptic in its interior.

When preparing the orthopedic rigid splint-plate orthosis 1 of thepresent invention for use, the physician, assistant or less skilledoperator cuts the upper part of the bag 9 and pours the boiling waterinside the bag 9. He then waits between one and two minutes to let thesplint-plate 2 warm into a soft state. Once the splint-plate 2 is soft,the end 10 of the bag 9 is cut to function like a funnel allowing thedischarge of the hot water. When practically all the water isdischarged, the necessary part of the bag will be cut in order to permitremoval of the splint-plate 2, which may then be placed directly overthe skin of the patient in the region to be treated.

The necessary shape of the splint-plate, as illustrated in FIGS. 3, 3Aand 4, is obtained by pressing with the fingers on the soft plate 2.Once the plate 2 is cooled, it reverts back to its original rigid state,where it will grip itself around the member of the patient and the strip3 will perform an accessory fastening function. An adhesive strip may beused for the strip 3. The entire preparation and casting operation takesonly a few minutes or so and requires no special instrumentation norhardly any skill.

Another important feature of the present orthosis is that, during thetherapeutic period or treatment, any necessary zone of the plate 2 maybe reheated and remoulded on the body of the patient, in order tocorrect the position of the splint 2, as well as to relieve any excesspressure exerted in such zones.

The use of the present invention in an operating theatre differssomewhat, insofar that initially the sealed bag 9 is enclosed in asecond .[.(not illustrated).]. .Iadd.9A shown in FIG. 5.Iaddend., whichis sealed and sprayed with ethylene oxide gas. The molecular aperturesof the plastic material used for the bags, e.g., nylon ar large enoughfor the gas molecules to pass through and too small for the microbes;hence, all contents of the bags are effectively sterilized until the bagis opened. Of course, other forms of gas or radiation may be employed.When needed, the pair of closed bags is submerged in hot water and, oncethe plate 2 has softened, the circulating nurse cuts open the outsidebag and the scrub nurse then opens the inside bag 9. Into neither of thetwo bags is hot water poured.

Another feature of the rigid splint-plate 2 of the present invention isthat the splint-plate 2 may be lined with a foam pad .[.(notillustrated).]. .Iadd.2B .Iaddend.on an inner face thereof, which linedface is intended to be in contact with the skin of the patient. This padsurface is intended to avoid hurting the skin of the patient, as well asto make the rigid splint 2 more comfortable. This pad surface may beperforated and may comprise a thermoplastic material. .Iadd.Also, theplate may be gridded with holes 2A to facilitate skin breathing as wellas saving material and providing a lighter splint. .Iaddend.

Although the essential features of the invention have been brought outby means of a preferred embodiment, the invention is not limited to thisembodiment and extends on the contrary to all alternative forms withinthe purview of the appended claims.

I claim:
 1. A method for immobilizing an injured body membercomprising:(a) opening .[.the.]. .Iadd.a .Iaddend.bag in a combinationcomprising a splint-plate .Iadd.and the bag, with the splint plate.Iaddend.inside .[.a water.]. .Iadd.the bag, the bag being liquid.Iaddend.impervious.Iadd., .Iaddend.aseptically closed .[.bag.].,mechanically resistant to the weight of the splint-plate and thermallyresistant to temperatures at or below the boiling point of water, thesplint-plate comprising a rigid thermoplastic plate pre-cut to conformto a specific body member .[.and provided with fastening means attachedthereon.].; (b) pouring a liquid into the opened bag, the liquid beingat a temperature at or below the boiling point of water and above thesoftening point of the thermoplastic splint plate; (c) allowing thesplint-plate to remain in the liquid until the splint-plate softens; (d)removing the softened splint-plate from the bag; (e) applying thesoftened splint-plate to a body member and molding it to fit the bodymember; and (f) securing the splint-plate in place around the bodymember .[.with the fastening means.]..
 2. The method according to claim1.Iadd., .Iaddend.wherein the softened splint-plate is removed from thebag by cutting the bottom of the bag to allow the liquid to drain fromthe bag.
 3. The method according to claim 1.Iadd., .Iaddend.wherein thesplint-plate is secured in place using at least one non-stretchablelinking strip, one end of the strip being connected to the splint-plateand the other end of the strip being provided with a locking means whichis engageable with a complementary locking means attached to thesplint-plate. .Iadd.
 4. The method according to claim 1, wherein thestep of securing comprises securing the splint-plate in place around thebody member with a fastening means attached to the splint-plate..Iaddend. .Iadd.5. A combination for immobilizing an injured body membercomprising an orthopedic splint-plate, a liquid-impervious, asepticallyclosed bag holding the splint-plate, the bag being mechanicallyresistant to the weight of the splint-plate and thermally resistant totemperatures at or below the boiling point of water, said bag beingprovided for receiving a hot liquid therein at or below the boilingpoint of water thereby to soften the splint-plate, the splint-platecomprising a rigid thermoplastic plate pre-cut to conform to a specificbody member, the thermoplastic plate being deformable to conform to thebody member after heating to a temperature at or below the boiling pointof water, and becoming rigid on the body member upon subsequent cooling,said splint-plate further comprising a plurality of holes therethroughwhich permit the circulation of air from one face of the splint-plate toits other face. .Iaddend. .Iadd.6. The combination according to claim 5,further comprising fastening means attached to the thermoplastic platefor securing the plate to the body member. .Iaddend. .Iadd.7. Thecombination according to claim 5, wherein the bag has a V-shaped bottompart which can easily be cut to discharge the contents of the bag..Iaddend. .Iadd.8. The combination according to claim 6, wherein thefastening means comprises at least one non-stretchable locking strip,one end of the strip being provided with a locking means which isengageable with a complementary locking means attached to thesplint-plate. .Iaddend. .Iadd.9. The combination according to claim 5,wherein the splint-plate has a face intended to contact the body membercomprising padding. .Iaddend. .Iadd.10. A combination for immobilizingan injured body member comprising an orthopedic splint-plate, aliquid-impervious, aseptically closed first bag holding thesplint-plate, the bag being mechanically resistant to the weight of thesplint-plate and thermally resistant to temperatures at or below theboiling point of water, the splint-plate comprising a rigidthermoplastic plate pre-cut to conform to a body member and beingdeformable to conform to the body member after being heated in the bagto a temperature at or below the boiling point of water and becomingrigid on the body member upon subsequent cooling, and further comprisinga second bag disposed about and sealing the first bag so that the secondbag containing the first bag with the splint-plate may be submerged in ahot liquid to soften the splint-plate without contact of the hot liquidwith said first bag and splint plate, said bags being permeable tosterilizing gas for sterilizing the splint-plate, but impermeable to thehot liquid and to microbes. .Iaddend. .Iadd.11. A combination forimmobilizing an injured body member comprising an orthopedicsplint-plate, a liquid-impervious, aseptically closed bag holding thesplint-plate, the bag being mechanically resistant to the weight of thesplint-plate and thermally resistant to temperatures at or below theboiling point of water, the splint-plate comprising a rigidthermoplastic plate pre-cut to conform to a body member, thethermoplastic plate being deformable to conform to the body member afterbeing heated in the bag to a temperature at or below the boiling pointof water and becoming rigid on the body member upon subsequent cooling,said bag being permeable to sterilizing gas for sterilizing thesplint-plate, but impermeable to hot liquid and to microbes. .Iaddend.